A leading global pharmaceutical manufacturer Hetero Group emerged the first company in the world to be accorded the World Health Organisation’s (WHO) prequalification of medicines programme (WHO-PQ) for its generic version of Covid-19 oral antiviral treatment candidate Nirmatrelvir.
This antiviral with Ritonavir is used as part of Pfizer’s Paxlovid. The company said it, “will be rolling out its generic combi-pack under the NIRMACOM brand that will contain 150mg tablets of Nirmatrelvir and 100mg tablets of Ritonavir.”
The WHO deemed the drug, Nirmatrelvir, the best option for high risk patients.
“This is the first prequalification for a generic version of Pfizer’s Covid-19 oral antiviral drug Paxlovid, which the WHO called the best therapeutic choice for high-risk patients to date,” Hetero said.
The tablets will be available on prescription only and have to be started within five days of onset of Covid-19 symptoms, it added. According to Hetero, Nirmacom will be manufactured at its facilities in Hyderabad.
The highly transmissible BF.7 Omicron variant of Covid-19 was highly unlikely to trigger another “wave” in the country, experts said, suggesting India should redefine a “surge or wave” to avoid panic in case localised or sporadic rise in caseloads is detected. “The worst-case scenario is that the
Terming the WHO PQ for Nirmacom as a significant milestone in the fight against Covid-19, Hetero Group managing director Vamsi Krishna Bandi said: “It allows us to expand access to this important innovative antiretroviral drug to people in need. We are committed to making NIRMACOM available faster at affordable prices across 95 LMICs including India.”
Medicines Patent Pool (MPP) executive director Charles Gore said: “We are delighted to see the first generic version of nirmatrelvir under MPP license with Pfizer, receive quality assurance approval from WHO. This is an impressive achievement from Hetero as we announced the sub-licence agreements just nine months ago. With cases of Covid-19 again on the rise we need to make treatments readily available in LMICs so no one is left behind.”
Hetero bags first world WHO prequalification of medicines programme generic version of Pfizer’s Covid-19 oral drug
